Summary of Product Characteristics
last updated on the eMC:
11/09/2007
When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC. For each version, we show the dates it was published on the eMC and the reasons for change.
Updated on 11/09/2007 and displayed until Current
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Reasons for adding or updating:
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Change to section 4.4 - Special warnings and precautions for Use
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Change to section 9 - Date of first Authorisation/renewal of the Authorisation
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| Date of revision of text on the SPC: 09/2007 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.4 - Special warnings and precautions for use - Deletion of text 'For external use only'
Section 9 - Renewal of the Authorisation - Date changed to '16 February 2006'
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Updated on 08/03/2007 and displayed until 11/09/2007
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Reasons for adding or updating:
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Change to section 4.4 - Special warnings and precautions for Use
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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 02/2006 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 4.4 - Special warnings and precautions for use: The following text has been added: "The excipient propylene glycol may on rare occasions cause skin irritation in sensitive people."
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Updated on 03/08/2004 and displayed until 08/03/2007
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Improved Electronic Presentation
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Updated on 23/09/2003 and displayed until 03/08/2004
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Improved Electronic Presentation
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Updated on 17/09/2002 and displayed until 23/09/2003
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Reasons for adding or updating:
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Change to section 10 (date of (partial) revision of the text
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Updated on 23/07/2001 and displayed until 17/09/2002
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Transferred from eMC version 1
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Updated on 17/04/2001 and displayed until 23/07/2001
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Updated on 18/12/2000 and displayed until 17/04/2001
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Updated on 06/09/1999 and displayed until 18/12/2000
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